pramipexole dihydrochloride
- Product NDC
- 29300-211
- 11-digit product format
- 293000211
- Labeler code
- 29300
- Product ID
- 29300-211_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA207011
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1.5 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pramipexole dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 858625, 859033, 859040, 859044, 859048, 859052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-211-10 | pramipexole dihydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 12 |
| 29300-211-19 | pramipexole dihydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-211 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240217_b978aa75-c62d-444b-9ec6-6c0d21a66688.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 29300-211-10 | 29300021110 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-211-10) | 1000 tablet | 2019-03-01 | 0000-00-00 | No | No | Current |
| 29300-211-19 | 29300021119 | 90 TABLET in 1 BOTTLE, PLASTIC (29300-211-19) | 90 tablet | 2019-03-01 | 0000-00-00 | No | No | Current |